Executive Forum

Dr. Paul Rupp introduced us to the securPharm project, a directive designed by the EU to fight the
on-going threat of falsified medicines.

Dr. Paul Rutten, Principal and McKinsey & Co, the Netherlands

Dr. Rutten taught us how to manage compliance and quality under new requirements and explained the
perceived trade-off to lean, agile and flexible production.

Dr. John Berridge, Strategic Advisor, ISPE

Dr. Berridge brought us up-to-date on the new association and regulatory initiatives that have been
initiated since the publication of the ISPE Drug Shortages Survey report in June 2013

Dr. Brendan Cuddy, Scientific Administrator, EMA

Brendan Cuddy shared with us information about the legal structure on drug production, as well as on the
major issues and causes for drug shortages in Europe. He also took a closer look at various EMA initiatives
and actions, and their implementation.

This session brought together representatives from all the associations contributing to an
Inter-Association Task Force that is responding to the EMA’s request to submit to them a report on how
shortages can be prevented.

Conference Tracks

Track 1: QbD - Reality Today? Implementation and Beyond

Track 1 highlighted the new quality paradigm that can be defined as a
shift from a pure compliance approach to a more proactive one. Meanwhile, quality should be secured by
integrating the risk management approach all along the scientific development.

A key objective in this track was to ensure the robustness of
manufacturing processes and to facilitate technological innovation, and the final goal is to provide high
tech and high quality pharmaceutical product to patients.

Track 2: Quality Risk Management (QRM)

Track 2 contributed to the ISPE Drug Shortages Prevention Plan, the
Society’s second major output on this topic since launching its Drug Shortages Initiative in 2012. This
second phase of the Initiative is aimed at addressing the root causes of drug shortages to prevent delay of
supply. The 2013 survey provided clear
evidence that mitigating shortages requires a holistic approach that encompasses both the organizational and
technical issues affecting drug manufacturing and quality.

The ISPE’s Drug Shortages Prevention Plan will feature an organization
and product lifecycle approach to ensure a more reliable supply of medicines through development of
company-wide drug shortages strategic plans, aligned governance, good communication, on-going capability
building (which includes training), proactive regulatory interaction and integrated quality
systems.

Track 3: Facilities of the Future

Track 3 focused on new manufacturing technology for commercial
manufacturing and proposed some flexible solutions for smaller batchers, shorter lead-times and
personalization of drugs. Finally, EMA and FDA made some observations and recommendations on how to handle
these facilities.